MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-07-12 for FROVA INTUBATING INTRODUCER C-CAE-14.0-70-FIC manufactured by William Cook Europe.
[113740244]
(b)(4). Name and address for importer site: (b)(4). Ec method code: (b)(4)- type of investigation not yet determined. Investigation is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[113740245]
Description of event according to initial reporter: she used the frova with a covidien dlt and when she explored the lungs and the airway she detected a small part of the frova. She could take the part of the frova with a clamp. Patient outcome: a section of the device did not remain inside the patient? S body. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808486-2018-00808 |
| MDR Report Key | 7680840 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-12 |
| Date of Report | 2018-08-22 |
| Date of Event | 2018-06-07 |
| Date Facility Aware | 2018-06-25 |
| Date Mfgr Received | 2018-07-27 |
| Date Added to Maude | 2018-07-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. THOMAS HESSNER KIRK |
| Manufacturer Street | SANDET 6 |
| Manufacturer City | BJAEVERSKOV DK-4632 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-4632 |
| Manufacturer Phone | 56868686 |
| Manufacturer G1 | WILLIAM COOK EUROPE |
| Manufacturer Street | SANDET 6 |
| Manufacturer City | BJAEVERSKOV DK-4632 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | DK-4632 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FROVA INTUBATING INTRODUCER |
| Generic Name | LRC INSTRUMENT, ENT MANUAL SURGICAL |
| Product Code | LRC |
| Date Received | 2018-07-12 |
| Returned To Mfg | 2018-07-04 |
| Catalog Number | C-CAE-14.0-70-FIC |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLIAM COOK EUROPE |
| Manufacturer Address | SANDET 6 BJAEVERSKOV 4632 DA 4632 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-12 |